Laparoscopic Versus Open Resection of Cancer Stomach Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- The number of lymph nodes in the postoperative spicement.
研究概览
简要总结
The aim of surgical procedures for resection of cancer stomach is to resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).
There are two main types of techniques (open & laparoscopic) Many studies were done comparing these two techniques showed that Laparoscopic resection is superior in early postoperative recovery (less pain ,less bleeding and shorter hospital stay) but less radical than open resection (less safety margin & less lymphadenectomy) but because of the ongoing advances on laparoscopic surgery these results needs more and more revision.
So the investigators conduct this randomized controlled trial aiming at comparing open and laparoscopic resection of cancer stomach to choose the best surgical procedure for resection of cancer stomach.
详细描述
The surgical procedure for resection of cancer stomach aiming at resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).
Tumor resection;
Will be done by one of the following techniques:
- laparoscopic gastrectomy (totally laparoscopic, laparoscopy-assisted, and hand-assisted) types of gastrectomy (according to site of tumour)
- Open gastrectomy (according to the site of tumor). # Lymphadenectomy; Will be done according to Japanese Gastric Cancer Association guidelines for optimal lymph node dissection levels for Early Gastric Cancer (1):
- D1+alpha -(perigastric lymph node dissection) for mucosal cancer, for which EMR is not indicated and for histologically differentiated submucosal cancer of < 1.5 cm in diameter;
- D1+ beta for preoperatively diagnosed submucosal cancer without lymph node metastasis (N0), for which D1+ alpha is not indicated, and for early cancer < 2.0 cm in diameter with only perigastric lymph node metastasis (N1);
- D2 for early cancer > 2.0 cm in diameter. Follow up: all patients will be followed up clinically for the outcomes for each surgical technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with primary carcinoma of the stomach, where the tumor is considered surgically resectable (T1-3, N0-1, M0).
排除标准
- •Pregnancy.
- •Infiltration to the( pancreas ,liver ,colon or vital vascular structure).
- •Metastasis to the (liver, lung, brain, paraaortic LN involvement).
- •Peritoneal deposit.
- •Surgically unfit patient.
结局指标
主要结局
The number of lymph nodes in the postoperative spicement.
时间窗: two weeks
considered a prognostic factor for disease-free postoperative survival The more the number of lymph nodes the more radicality of the procesure
次要结局
- Mortality(30 days post-operative)
- Postoperative complications(Postoperatively with follow-up to one year)
- Peri-operative blood loss(during surgery, 1 day)
- Duration of Surgery(Peri-operatively, 1 day)
研究者
Mohamed Gamal Ameen Taher
Assistant lecturer
Assiut University